MAUDE Adverse Event Report: RICHARD WOLF GMBH WORKING ELEMENT PASSIVE BIPO

Model Number	8680.224
Health Effect - Clinical Code	Burn, Thermal (2530)
Date of Event	11/30/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Rwmic considers this case open.The user facility and manufacturer will be contacted again in an effort to collect missing information.
Event or Problem Description
On (b)(6) 2018, richard wolf medical instruments corporation (rwmic) was served with a patient lawsuit involving a "button type bipolar prostate resector and/or electrosurgical generator".On (b)(6) 2016, the patient underwent a procedure described as "cystoscopy with urethral dilation, transurethral resection/ablation of prostate with bipolar".During said procedure, the patient was under general anesthesia and suffered thermal injury to their bladder and urethra.At this time, the involvement of richard wolf products has not been confirmed.However, the following are considered suspect products and mdrs will be submitted for each until the user facility is able to confirm that no richard wolf products were involved: 8680.225 working element passive bipo 0/12/30 (mdr 1418479-2018-00051), 8680.224 working element passive bipo 0/12/30 (mdr), 46300223 bivap electrode bipo 22fr 12/30 (mdr 1418479-2018-00053), 46300243 bivap electrode bipo 24-26fr 12/30 (1418479-2018-00054).

• Brand Name: WORKING ELEMENT PASSIVE BIPO
• Common Device Name: WORKING ELEMENT PASSIVE BIPO
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 8237997
• Report Number: 1418479-2018-00052
• Device Sequence Number: 19380532
• Product Code: FDC
• UDI-Device Identifier: 04055207042946
• UDI-Public: 04055207042946
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K062720
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/10/2018
• Report Date (Section F): 01/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 8680.224
• Device Catalogue Number: 8680.224
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/10/2018
• Event Location: Hospital
• Date Report to Manufacturer: 01/10/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2018
• Initial Report FDA Received Date: 01/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 58 YR
• Date Report Sent to FDA: 01/10/2019